Laboratory automation and laboratory informatics Building a Smart Laboratory 2012
such as scientific data management systems (SDMS), chromatography data system (CDS) and electronic laboratory notebooks (ELN), as well as various related data systems that may be interfaced to any of these systems, or that operate independently. It also includes analytical instruments, chromatographs and other sources of laboratory observations shown in the lower half of Figure 2. Data can be transferred to the LIMS by a
variety of means: • Direct data capture from an instrument interfaced to the LIMS;
• Data capture from an instrument with analysis and interpretation by the attached data system and only a result is transferred to the LIMS;
• As above, but the results or electronic records are transferred to the LIMS via a scientific data management system;
• Laboratory observations can be written into a notebook then entered manually into the LIMS or captured electronically via an electronic laboratory notebook (ELN) and transferred electronically to LIMS.
A pre-requisite before implementing a LIMS, or indeed any major computerised system, is to map and optimise the laboratory processes that the LIMS will automate. Te lab needs to understand the process and identify any bottlenecks and their underlying cause(s). Tis is especially important when
moving from a paper-based to an electronic environment due to the fact that most lab processes have evolved over time rather than being specifically designed to meet organisational requirements. Moreover, the processes are paper-based rather than electronic. Refer to reference 10 for further information about the LIMS matrix. Te aim for any LIMS implementation is for a simplified and streamlined electronic process, rather than the automation of an inefficient and paper-based status quo.
What is an LES?
Historically, electronic laboratory notebooks (ELN) have been designed to accommodate the unstructured data typically found in research laboratories. Researchers should be able to record scientific data, make observations, describe procedures, include images, drawings and diagrams and collaborate with others to find new chemical compounds, biological structures, etc., without any limitation. In a research environment, workflows are oſten methodical
12 Data System Fig. 3: Diagram of a LIMS environment
Electronic Document Management System (EDMS)
Enterprise
Resource Planning (ERP) System
Specification Management System
Laboratory Information Management System (LIMS)
Scientific Data Management System
CDS System
Electronic Lab Notebook
Data System
Data System
Analytical Instruments
Chromatographs
Laboratory Observations
but unscripted, and qualitative characteristics are oſten most important. In QA/QC analytical labs the routine sample-processing paradigm dominates. Workflows are more repeatable and data is oſten much more structured and quantitative. Analysts, therefore, need a structured and robust platform to ensure that proper procedures are followed, that the progression of samples through the lab is tracked and that discrete measurement data is captured and reported reliably. Analytical services and quality control
laboratories frequently deploy systems to automate high-volume workflows and ensure compliance. In addition, many of the same needs and characteristics hold true for analysts working in core sequencing and genotyping laboratories that support R&D, clinical diagnostics labs, and the like. Traditionally in these laboratories LIMS have been very successful. In recent years, however, another category of informatics tool has emerged and is gaining significant popularity. Tis category of informatics products is oſten referred to as laboratory execution systems (LES) and they range in functionality from the simple to the quite complex. An LES is designed to support analysts’
daily workflows in a natural language form and typically provide the analyst with a User Interface (UI) that closely resembles existing
lab worksheets and/or standard operating procedures (SOP). Ultimately, whether it appears as electronic laboratory worksheets augmenting LIMS functionality or as a standalone application, the LES serves the analyst by guiding them through reproducible workflows, managing the associated data and helping to ensure compliance. An LES will extend the usability of LIMS or
ERP/QM systems, because the user interface is more focused toward how the scientists operate in the laboratory. LIMS and enterprise ERP systems are oſten designed by technicians, business and IT specialists. Since many laboratory operations are specialised due to the scientific nature of the operation, the user experience is very critical to assure acceptance. LES are fundamentally written with the end user in mind and oſten operate in natural language, or mimic existing paper forms as electronic and automated equivalents. Tis is oſten referred as ‘Paper on Glass’
in the market. In a QA/QC lab, standard operating procedures are developed to ensure the accuracy and consistency of sample data. It is essential that the SOP be followed exactly for each and every analysis to eliminate the risk of the measurement process being a variable. In this way, if a test result is out of range, it is more likely to be related to the sample and not the testing procedure.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36